- Lonza to manufacture CASGEVY®, the world’s first CRISPR/Cas9 gene-edited cell therapy, for global commercial supply
- CASGEVY® will be manufactured at Lonza’s Geleen (NL) cell therapy manufacturing facility with plans to expand to Portsmouth, NH (US)
- Geleen (NL) site is now approved by the FDA, EMA and MHRA for the commercial production of CASGEVY®
Basel, Switzerland, 24 September 2024 – Lonza, a global manufacturing partner to the pharmaceutical, biotech and nutraceutical markets, announced today the signature of a long-term commercial supply agreement for CASGEVY® (exagamglogene autotemcel).
CASGEVY® is the first cell therapy based on the CRISPR/Cas9 technology, discoverers of which were awarded the Nobel Prize in Chemistry in 2020. CASGEVY® offers the potential of a one-time treatment for eligible patients with transfusion-dependent beta-thalassemia or sickle cell disease.
Under the terms of the agreement, Vertex will leverage Lonza’s scientific, regulatory and manufacturing expertise, global manufacturing network, and first-hand experience in the commercial manufacture of cell therapy products. Lonza will manufacture CASGEVY® at the state-of-the-art cGMP cell therapy manufacturing facilities in Geleen (NL), with plans to expand to its Portsmouth (US) facility.
The Geleen (NL) cell manufacturing facility was recently granted a GMP license by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Medicines and Healthcare Products Regulatory Agency (MHRA). The Portsmouth (US) site is expected to begin GMP operations in 2025.
Daniel Palmacci, President, Cell & Gene, Lonza, commented: “It is a privilege to work with Vertex on bringing its innovative and cutting-edge medicines to patients suffering from life-threatening diseases. We are also pleased to reach a significant milestone towards supporting the commercial manufacture of CASGEVY® by receiving the regulatory approval at our state-of-the-art cell therapy manufacturing site in Geleen.”
Morrey Atkinson, Ph.D., Executive Vice President and Chief Technical Operations Officer, Head of Biopharmaceutical Sciences and Manufacturing Operations, Vertex, added: “Manufacturing a first-of-its-kind therapy like CASGEVY® is complex and requires advanced technology and capabilities. The Lonza team have been excellent partners as we have invested in our global manufacturing network to ensure CASGEVY® will be available for the patients who need it. We look forward to our continued collaboration.”
About Lonza
Lonza is one of the world’s largest healthcare manufacturing organizations. Working across five continents, our global community of around 18,000 colleagues helps pharmaceutical, biotech and nutrition companies to bring their treatments to market. United by our vision to bring any therapy to life, we support our customers with a combination of technological insight, world-class manufacturing, scientific expertise, process excellence and innovation. Our work enables our customers to develop and commercialize their therapeutic discoveries, allowing their patients to benefit from life-saving and life-enhancing treatments.
Our business is structured to meet our customers' complex needs across four divisions: Biologics, Small Molecules, Cell & Gene, and Capsules & Health Ingredients. Our company generated sales of CHF 6.7 billion with a CORE EBITDA of CHF 2.0 billion in Full-Year 2023. Find out more at www.lonza.com
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Additional Information and Disclaimer
Lonza Group Ltd has its headquarters in Basel, Switzerland, and is listed on the SIX Swiss Exchange. It has a secondary listing on the Singapore Exchange Securities Trading Limited (“SGX-ST”). Lonza Group Ltd is not subject to the SGX-ST’s continuing listing requirements but remains subject to Rules 217 and 751 of the SGX-ST Listing Manual.
Certain matters discussed in this news release may constitute forward-looking statements. These statements are based on current expectations and estimates of Lonza Group Ltd, although Lonza Group Ltd can give no assurance that these expectations and estimates will be achieved. Investors are cautioned that all forward-looking statements involve risks and uncertainty and are qualified in their entirety. The actual results may differ materially in the future from the forward-looking statements included in this news release due to various factors. Furthermore, except as otherwise required by law, Lonza Group Ltd disclaims any intention or obligation to update the statements contained in this news release.
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